Surgical positioning system

ABSTRACT

A surgical positioning system includes a flexible air-impermeable shell filled with beads that is wrapped against the patient and subjected to a vacuum to hold the patient in place. An air-impermeable top wall can be joined with an air-impermeable bottom wall to define a plurality of chambers. Each of the chambers can include a peripheral edge that extends around the periphery of the respective chamber. The plurality of chambers can include a first shoulder chamber, a second shoulder chamber, and a main chamber.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/051,937, filed Mar. 18, 2011, issued as U.S. Pat. No. 8,690,807,which is a continuation-in-part application of U.S. application Ser. No.13/011,686, filed Jan. 21, 2011, issued as U.S. Pat. No. 8,690,806,which is a continuation-in-part application of U.S. application Ser. No.12/584,337, filed Sep. 2, 2009, issued as U.S. Pat. No. 8,469,911, eachof which is hereby incorporated by reference herein in its entirety.

FIELD

This invention relates to an improved positioning system for supporting,restraining and/or immobilizing a patient during medical treatment.

BACKGROUND

Vacuum actuated positioning aids or devices are utilized in theoperating room for positioning patients in the supine, prone and lateralpositions. They are frequently used when the patient is in the lateralposition, i.e., on his or her side, for a multitude of surgicalprocedures, such as brain, chest, kidney, shoulder and hip surgery, toname a few. The devices typically comprise a flexible air impervious bagcontaining small particles or beads which consolidate into a rigid masswhen the bag is evacuated. See, for example, U.S. Pat. No. 3,762,404 toSakita and U.S. Pat. No. 5,906,205 to Hiebert. Devices according to theHiebert patent are sold by Hug-U-Vac under the trademark HUG-U-VAC®.

More specifically, devices of this type typically are filled withthousands of tiny, elastically deformable, generally spherical,polystyrene or plastic beads. When the device is in the soft(unevacuated) condition, the beads are free to move around so that thedevice can be molded to the patient's body. When air is removed (using avacuum source), atmospheric pressure forces the beads together into asolid mass, positioning yet immobilizing the patient in the selectedposition. Allowing air back into the device returns it to its initialsoft condition, ready for re-use.

These positioning devices, sometimes referred to as bean bagpositioners, typically have a generally square or rectangular shape andin some cases are provided with a U-shaped shoulder cutout locatedcentrally along one edge. One line of bean bag and “vacuum pac”positioners is offered by SW Med-Source, P.O. Box 93115, Southlake, Tex.(www.swmedsource.com). SW Med-Source offers gel bean bag positioners aswell. Another line of Olympic Vac-Pac® bean bag positioners is offeredby Natus Medical Incorporated, 1501 Industrial Road, San Carlos, Calif.(www.natus.com).

Fabric-style devices also are used for positioning patients during examor treatment. These devices typically are wrapped around one or moresections of the patient, and include one or more wide canvas flaps withadjustable Velcro™ straps. The flaps may be detached/unwrapped to allowa particular area of the patient to be selectively exposed fortreatment. See, for example, Natus' Olympic Papoose Boards®(www.natus.com).

Foam pads and other positioning aids also are used to reduce pressurepoints and provide patient support during surgery.

There remains however a need for an improved positioning system forsurgery in which the patient is in a supine position, especiallysurgeries in which the patient is supported on an inclined surgery tableas, for example, when the patient is in the Trendelenburg, ReverseTrendelenburg or Lateral Oblique positions.

In the Trendelenburg position, the patient is laid flat on her back withher feet above her head. This position may be used during certainlaparoscopic and other procedures such as colectomies, hysterectomies,prostatectomies and robotic procedures. In some procedures, the angle ofincline is so steep that the patient is in a so-called SteepTrendelenburg position. In the Reverse Trendelenburg position, thepatient is tilted in the opposite direction with his head above hisfeet.

Accordingly, it is desirable to provide an improved positioning systemfor patients positioned in a supine position during surgery, especiallysurgeries requiring the patient to be oriented in an inclined positionrather than a perfectly horizontal supine position.

It also is desirable to provide an improved positioning system forcertain types of surgeries including, for example, laparatomies,laparoscopic procedures, colorectal procedures, gynecologicalprocedures, neurological procedures, cholecystectomies, NissinFundoplications and da Vinci procedures.

It is further desirable to provide an improved positioning system forsupine patients with better head and neck support.

It is also desirable to provide, at least in some embodiments, animproved positioning system that can be used with bariatric patients.

SUMMARY

In one example, a surgical positioning device for positioning the bodyof the patient in a selected position includes a flexible andair-impermeable shell having an air-impermeable top wall joined with anair-impermeable bottom wall, the shell defining an air-impermeable outerperiphery. The outer periphery of the shell includes an upper edge, alower edge and opposing first and second lateral edges extending betweenthe upper edge and lower edge, and defines a laterally extending midlineextending between the opposing lateral edges. An upper portion of theshell extends between the laterally extending midline and the upperedge. A lower portion of the shell extends between the laterallyextending midline and the lower edge. A central region for supportingthe patient's torso straddles the laterally extending midline andextends between the upper portion and lower portion. The upper portionincludes opposing first and second shoulder support regions positionedlaterally outward of the central region and adjacent the upper edge forsupporting the patient's respective shoulders.

In another example, the lower edge defines a longitudinally recessedperineal access region for providing access to the patient's perinealregion.

In another example, the upper portion includes rounded shoulder portionseach having a radius of curvature that generally increases as theshoulder portion extends laterally outwardly toward its respectivelateral edge. The width of the device at the shoulder portions and atits widest point is such that the device may be wrapped up and partiallyover the shoulders and proximate to the neck of a patient lying in asupine position.

In one example, the device is filled with many small beads, allowing thedevice to be pliable and conform to a patient's anatomy.

In another example, the lower portion includes opposed wrist portionswhich project laterally outwardly near the lower edge of the device. Thedevice has a width dimension at the wrist portions that allows thedevice to be wrapped upwardly to provide lateral support for a patient'shands, wrists and thighs when the patient is in a supine position.

In yet another example, the opposed lateral edges of the device includea tapered waist portion located between the wrist portions and a pointproximate the midline to give the device a low profile in the vicinityof the patient's wrists, forearms and lower lateral abdomen so as toprovide greater surgical access in these areas, IV access, and accessfor surgical instruments.

In yet another example, the upper portion provides an adjustable pillowportion to support the patient's neck and head.

A method of supporting the patient in a supine position includespositioning a flexible air-impermeable shell between a patient and asupport, such as an operating table. The shell has an upper edge and alower edge and opposing first and second lateral edges extending betweenthe upper edge and lower edge. The shell defines a laterally extendingmidline extending between the opposing lateral edges, and includes firstand second shoulder support regions positioned adjacent the upper edgeand a longitudinally recessed perineal access region adjacent the loweredge. When the patient is in the supine position, the first and secondshoulder support regions are folded upwardly to at least partiallyengage each of the patient's shoulders. The shell is then substantiallyevacuated such that the first and second shoulder support regionssupport and retain in place each of the patient's respective shoulders.

In another example, a method of supporting a patient includes urgingfirst and second upper arm support regions of the shell to at leastpartially engage each of the patient's respective upper arms, such thatwhen the shell is evacuated the first and second upper arm supportregions at least partially matingly engage each of the patient's upperarms.

In a further example, a method of supporting a patient includesadjustably inflating the pillow portion to provide appropriate supportfor the patient's head and neck.

In another example, a surgical positioning device for positioning thebody of a patient in a selected position includes first, second, andthird chambers. Each has an air-impermeable top wall joined with anair-impermeable bottom wall and top edges, bottom edges, and lateraledges. The second and third chambers are positioned on opposing sides ofthe first chamber such that at least a portion of one of the lateraledges of the second chamber is positioned adjacent a portion of one ofthe lateral edges of the first chamber, and at least a portion of one ofthe lateral edges of the third chamber is positioned adjacent a portionof a different lateral edge of the first chamber.

In another example, at least a portion of the bottom edge of the secondchamber is positioned adjacent an edge of the first chamber, and atleast a portion of the bottom edge of the third chamber is positionedadjacent a different edge of the first chamber. Each of the first,second, and third chambers can include separate valve systems, allowingfor independent evacuation of air from the respective chambers. Each ofthe valve systems can also include a locking member configured torestrict movement of the valve systems to an open configuration thatallows ingress of air into the respective chamber.

In some examples, a single sheet of air-impermeable material forms thetop walls of the first, second, and third chambers, and a single sheetof air-impermeable material forms the bottom walls of the first, second,and third chambers. The first chamber can also include an upper portionthat extends between a laterally extending midline and the upper edge ofthe first chamber and a lower portion that extends between the laterallyextending midline and the lower edge of the first chamber. The secondand third chambers can be positioned on opposing sides of the upperportion of the first chamber.

In another example, opposing strap-receiving members can be positionedat opposing lateral edges of the lower portion of the first chamber, andthe strap-receiving members configured to receive a strap to secure thepatient and positioning device to an operating table. The lower portioncan also include opposing first and second hand and/or wrist supportregions that are positioned laterally outward of a central region andadjacent a lower edge of the lower portion for supporting the patient'srespective hands and/or wrists. In some examples, a plurality of strappatches can be secured to the bottom wall of the first chamber forreceiving a plurality of straps to secure the surgical positioningdevice to an operating table. Also, a head support region can beprovided adjacent to and generally centered relative to an upper edge ofthe first chamber and an open perineal access region can be provided ata bottom edge of the first chamber, the access region being generallycentered relative to the bottom edge.

In some examples, a plurality of beads can substantially fill each ofthe first, second, and third chambers and the beads can be configured toallow the chambers to remain pliable until air is evacuated from arespective chamber.

In another example, a surgical positioning device includes a flexibleand air-impermeable shell comprising an air-impermeable top wall joinedwith an air-impermeable bottom wall to define a plurality of chambers.Each of the chambers can include a peripheral edge that extends aroundthe periphery of the respective chamber. The plurality of chambers caninclude a first shoulder chamber, a second shoulder chamber, and a mainchamber. The main chamber can include a central region and upper regionfor supporting at least a portion of a torso of the patient, with theupper region extending between the first and second shoulder chambers sothat the first and second shoulder chambers extend laterally outward ofthe upper region for supporting the patient's respective shoulders. Atleast a portion of a lateral edge of the first shoulder chamber can beadjacent to a portion of a lateral edge of the main chamber and at leasta portion of a lateral edge of the second shoulder chamber can beadjacent to a portion of another lateral edge of the main chamber. Also,at least a portion of bottom edges of the first and second shoulderchamber can be adjacent to portions of the peripheral edge of the mainchamber.

In one example, the main chamber can include a separate valve systemfrom the first and second shoulder chambers, such that air can beevacuated from the main chamber independently of the first and secondshoulder chambers. A locking member for the valve systems can beprovided. The locking member can be configured to restrict movement ofthe valve systems to an open configuration that allows ingress of airinto a respective chamber.

In some examples, opposing strap-receiving members can be positioned atopposing lateral edges of the central region of the main chamber, withthe strap-receiving members being configured to receive a strap tosecure the patient and positioning device to an operating table. Aplurality of strap patches can also be secured to the bottom wall forreceiving a plurality of straps to secure the surgical positioningdevice to an operating table.

In other examples, a head support region can be provided adjacent to andgenerally centered relative to an upper edge of the main chamber and anopen perineal access region can be provided at a bottom edge of the mainchamber, the access region being generally centered relative to thebottom edge. A plurality of beads can substantially fill each of themain chamber, the first shoulder chamber, and the second shoulderchamber, with the beads being configured to allow the chambers to remainpliable until air is evacuated from a respective chamber.

In another example, a method of supporting a patient in a supineposition with a surgical positioning device is provided. The methodincludes positioning a flexible and air-impermeable shell having aplurality of chambers between a patient and a support, the plurality ofchambers including a main chamber and opposing first and second shoulderchambers; urging the first and the second shoulder chambers to at leastpartially engage each of the patient's respective shoulders;substantially evacuating the main chamber such that the main chamberengages and at least partially immobilizes a torso of the patient;substantially evacuating the first shoulder chamber such that the firstshoulder chamber at least partially engages one of the patient'srespective shoulders; and substantially evacuating the second shoulderchamber such that the second shoulder chamber at least partially engagesanother of the patient's respective shoulders.

In some examples, the main chamber is evacuated before the evacuation ofthe first and second shoulder chambers. In other examples, the methodincludes forming irregular surfaces at peripheral edges of the mainchamber by the evacuation of the main chamber and forming irregularsurfaces at peripheral edges of the first and second chambers by theevacuation of those chambers. The main chamber is positioned between thefirst and second shoulder chambers so that the irregular surfaces ofeach of the first and second shoulder chambers engage and interlock withadjacent irregular surfaces on the main chamber to restrict relativemovement between the main chamber and the first and second shoulderchambers.

In some examples, the main chamber includes opposing first and secondhand and/or wrist support regions. The method can also include urgingthe first and the second hand and/or wrist support regions to at leastpartially engage each of the patient's respective hands and/or wrists,wherein upon substantially evacuating the shell, the first and thesecond hand and/or wrist support regions at least partially matinglyengage each of the patient's respective hands and/or wrists.

In some examples, each of the chambers can include a valve system topermit independent evacuation of the respective chambers. The method caninclude securing the valve systems in a locked position to restrictingress of air into the respective chambers. The act of securing thevalve systems can include positioning a C-shaped lock member on thevalve systems to restrict movement of the valve systems into an unlockedposition.

In another example, securing the shell to the support can include usingat least one fastening strap that is coupled to a bottom wall of theshell. In other examples, the method can include securing the patientand the shell to the support after evacuating all of the chambers bypositioning a strap around the patient and through at least twostrap-receiving members provided at lateral edges of the main chamber.

The foregoing and other objects, features and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of an embodiment of a surgical positioningsystem.

FIG. 2 is a bottom plan view of the embodiment of FIG. 1.

FIG. 3 is a perspective view of one portion of the FIG. 1 embodiment.

FIG. 4 is a top plan view of the FIG. 1 embodiment, patient andoperating table.

FIG. 5 is a sectional view taken along line 5-5 in FIG. 4.

FIG. 6 is a perspective view of the FIG. 1 embodiment and showing apatient in the Reverse Trendelenburg position.

FIG. 7 is a perspective view of the FIG. 1 embodiment and showing apatient in the Trendelenburg as well as Lateral Oblique position.

FIG. 8 is a top plan view of a slipcover used in conjunction with theFIG. 1 embodiment.

FIG. 9 is a top plan view of a slipcover material with a patternindicated thereon.

FIG. 10 is a top plan view of an embodiment of a surgical positioningsystem.

FIG. 11 is a bottom plan view of the embodiment of FIG. 9.

FIG. 12A is a partial cross-sectional end view of a surgical positioningsystem.

FIG. 12B is a partial cross-sectional end view of the surgicalpositioning system of FIG. 12, shown with chambers in an evacuatedstate.

FIG. 13 is a top plan view of an embodiment of a surgical positioningsystem.

FIG. 14 is a perspective view of a locking mechanism for use with asurgical positioning system, showing the mechanism in an unlockedposition.

FIG. 15 is a perspective view of a locking mechanism for use with asurgical positioning system, showing the mechanism in a locked position.

DETAILED DESCRIPTION

This disclosure makes reference to the accompanying drawings which forma part hereof, wherein like numerals designate like parts throughout.The drawings illustrate specific embodiments, but other embodiments canbe formed and structural changes can be made without departing from theintended scope of this disclosure. Directions and references (e.g., up,down, top, bottom, left, right, rearward, forward, etc.) can be used tofacilitate discussion of the drawings but are not intended to belimiting. For example, certain terms can be used such as “up,” “down,”,“upper,” “lower,” “horizontal,” “vertical,” “left,” “right,” and thelike. These terms are used, where applicable, to provide some clarity ofdescription when dealing with relative relationships, particularly withrespect to the illustrated embodiments. Such terms are not, however,intended to imply absolute relationships, positions, and/ororientations. For example, with respect to a positioning system, an“upper” surface or portion can be a “lower” surface simply by alteringthe position of the positioning such as by placing the positioningsystem on a tilted operating room table. Nevertheless, it is still thesame surface and the object remains the same. As used herein, “and/or”means “and” as well as “and” and “or.”

Accordingly, this detailed description shall not be construed in alimiting sense, and following a review of this disclosure, those ofordinary skill in the art will appreciate the wide variety of systemsthat can be devised and constructed using the various concepts describedherein. Moreover, those of ordinary skill in the art will appreciatethat the exemplary embodiments disclosed herein can be adapted tovarious configurations without departing from the disclosed concepts.Thus, in view of the many possible embodiments to which the disclosedprinciples can be applied, it should be recognized that theabove-described embodiments are only examples and should not be taken aslimiting in scope.

Referring to FIGS. 1 and 2, a surgical positioning system describedherein includes a generally flat bag 12 fabricated of flexible, airimpermeable material. The bag preferably is about 1½ to 2½ inches thick.One suitable material is “Rocheux Supreme” polyvinyl waterbed film,distributed by Rocheux International, Inc., Carson, Calif., althoughother materials having similar physical properties may be used. TheRocheux material has desirable low temperature, tear, heat sealing andflexing qualities, as well as superior hydrostatic resistance whichmakes it particularly suitable for the present positioning system. Italso has good resilience, returning quickly to its prior conformation,thereby holding the patient more securely. It is mildew-, bacteria-,puncture- and fire-resistant. Its physical properties are specificallyas follows:

Thickness (inches) 0.024, +5%, −0 ASTM D-751 Embossing Plain Weight(oz./yd.²) 17.5 (min.) ASTM D-751 Volatility (% loss) 1.5 (max) ASTMD-1203-86, Method B Elongation (%) 350-360 (min) ASTM D-882 Elongatechange after Less than 10 ASTM D-882 14 days × 150° F. (%) Breakingstrength 44 ASTM D-882 factor (psi) Tensile change after Less than 10ASTM D-882 14 days × 150° F. (%) Graves tear (lbs.) 5.6 (min) ASTMD-1004 Low temperature (° F.) −20 (min) ASTM D-1790 Dimensionalstability −5 (max) ASTM D-1204 (%) Specific gravity 1.21-1.23 ASTM D-792Mildew resistance Passes California Bureau of ATCC No. 6275 HomeFurnishings, Bulletin 128 Bacteria resistance Passes California Bureauof ATCC No. 6538, Home Furnishings, 4352 Bulletin 128 Hydraulicresistance 75 ASTM D-75 1 (psi) Puncture resistance   34.3 CaliforniaBureau of (lbs.) Home Furnishings, Bulletin 100

In another preferred embodiment, the flexible impermeable material canbe a urethane material.

The bag 12 includes top and bottom opposing walls 14, 16 which are radiofrequency welded, heat sealed or otherwise joined together at theirupper, lower and lateral edges 18, 20, 22 for strength and airtightness.The bag's preferred width at its widest point is about 42 inches, whichexceeds the shoulder width of most patients. The bag's preferred lengthat its longest point is about 46 inches, which corresponds generally tothe distance between the neck and upper thighs of an average heightpatient. Thus, when the patient is placed in the supine position on thebag 12, as shown in FIG. 4, the lateral edges 22 can be folded up alongthe patient's neck, shoulders, arms, hips and upper thighs and packedsnuggly against the patient's body to accommodate the natural contoursthereof.

Referring again to FIGS. 1 and 2, the upper edge 18 includes two opposedshoulder edge portions 24 a, 24 b, and a pillow edge portion 26 locatedtherebetween. Adjacent to the pillow edge portion 26, the shoulder edgeportions 24 a, 24 b have a relatively tight radius of curvature,preferably about 4⅜ inch, allowing the upper edge 18 to be foldedupwardly adjacent either side of the patient's head and neck forsupport. As upper edge 18 extends laterally outwardly toward edges 22,the upper edge retains an arc-like curvature but the radius of curvatureof shoulder edge portions 24 a, 24 b increases significantly, preferablyto about 22 to 23 inches, to expand the width of the bag and allow theupper edge (when folded) to wrap around and at least partially overliethe patient's shoulders to support and immobilize the patient's upperbody. The shoulder portions 24 a, 24 b of the upper edge 18 terminatewhere lateral edges 22 a, 22 b begin, defining the widest point of thebag.

Lateral edges 22 a, 22 b each define opposed cut-out portions 28 a, 28b, and opposed projecting wrist supporting portions 30 a, 30 b. Wristsupporting portions 30 a, 30 b project outwardly to increase the widthof the bag in the region proximate the lower edge 20. The width of thebag across the wrist supporting portions preferably is about 35 inches.The wrist supporting portions may be folded upwardly to provide lateralsupport for the patient's wrists and hands. They help secure thepatient's wrists and hands against the side of the patient's body. Thecut out portions 28 a, 28 b give the bag a tapered waist and low profilein the vicinity of the patient's arms so as to provide easy access tothe patient's wrists and forearms for insertion of an IV, surgicalaccess to the lower lateral abdomen, access for surgical instruments andother purposes.

The lower edge 20 preferably includes a central trapezoid-like cut out32 to provide perineal access. The cut out 32 preferably conforms toperineal access cut outs sometimes used in operating room table designsto provide access for speculums, rectal instruments and the like.

As shown in FIG. 2, a plurality of strap patches 34 a, 34 b, 34 c (threeshown) are secured by heat sealing, radio frequency welding or otherwiseto the bottom wall 16. The patches preferably are centered and spacedapart along the bag's longitudinal centerline/axis. Before the strappatches are attached to the bottom wall, an elongate fastener strap 38a, 38 b, 38 c, is attached, preferably by sewing or other fixedattachment method, to each patch 34 a, 34 b, 34 c. FIG. 2 shows the endsof each strap doubled back on each other for purposes of illustration.The fastener straps 38 a, 38 b, 38 c (FIGS. 7, 8) secure the bag 12 toan operating table 40 (FIG. 4) on which the bag and patient aresupported. Each strap has a fastening means to fasten one end of thestrap to the other or, when looped around an anchor, to itself to safelysecure the bag 12 to the operating table and thereby prevent the bagfrom sliding relative to the operating table. The fastening meanspreferably includes Velcro® brand hook-and-loop fastening means orequivalent hook-and-loop fasteners, although adjustable buckle style,clip and other tie down straps will suffice. More specifically, each endof the straps may be looped around an operating table side rail, D-ringor other anchor structure on the table 40, and then secured back toitself using hook-and-loop fasteners or other fastening means.Alternatively, the two ends of each strap may be secured to one anotheralong the underside of the operating table 40, depending on the designof the table.

In another embodiment, the straps can be formed of ballistic nylon.Also, instead of a Velcro®-type fastener, a buckle or other suchfastening system (e.g., a D-Ring system, etc.) can be used to secure theends of the straps to one another.

It will be appreciated that once the straps are secured to the operatingtable, the fixed attachment of the straps to the strap patches 34 a, 34b, 34 c (and effectively to the bag 12 as well), keep the bag fromsliding laterally on the operating table as, for example, when the tableis tilted laterally to place the patient in the Trendelenburg andLateral Oblique position.

Before walls 14, 16 are joined together to form the enclosed bag 12, thebag is filled with a charge of elastically deformable plastic beads 42(FIG. 5). The beads preferably are made of expanded plastic materials,such as polystyrene or polyvinyl chloride, because of their highmechanical strength, elastic deformability and low specific gravity.Beads 42 of expanded polystyrene are especially preferred. When the bag12 is in the unevacuated condition, the beads 42 remain loose within thebag such that the upper, lower and lateral edges of the bag can beeasily moved or folded up along the side of the patient's neck,shoulder, arms, hips and upper thighs to cradle and support the patientin the selected position. The bag preferably is configured to wraparound and overlie at least a portion of the patient's shoulders andupper chest, as shown in FIG. 4.

The bottom wall 16 of the bag 12 is provided with a valve 44 (FIG. 2)which communicates with the interior of the bag for evacuating airtherefrom. The valve 44 may be identical or similar to the one describedin U.S. Pat. No. 5,906,205, the disclosure of which is hereinincorporated by reference. The valve may have a male portion with aprotruding valve stem and a plastic tube which connects the valve stemto the bottom wall 16 in an airtight manner. The valve also preferablyincludes a female portion that may be releasably placed over the maleportion to depress the valve stem and open the valve to allow ingress oregress of air. When a source of vacuum is attached to the femaleportion, air is withdrawn from the interior of the bag. This causes theplastic beads 42 to be packed (or to congregate) into a tightconfiguration, conforming to the patient's body, as shown in FIGS. 6 and7. When the female portion is removed from the male portion, the valvecloses and no air can enter or exit the bag, thereby maintaining theconformity of the bag to the patient's body. When the patient is to bereleased, the female portion of the valve 44 (without the vacuum hoseattached) is placed over the male portion. This opens the valve 44,thereby allowing air to enter the bag and loosening the configuration ofthe beads so that they reside in a more relaxed, fluid state. Thisallows the bag to flatten. It will be appreciated that a variety ofconventional valves can be used to withdraw air from the bag, maintainthe bag in an evacuated state and allow air to reenter the bag.

As shown in FIGS. 1, 2 and 3, the bag 12 includes an inflatable pillow46 which is attached to a cut out portion in the bag located centrallyalong upper edge 18 between shoulder edge portions 24 a, 24 b. There isno fluid communication between the interiors of the bag 12 and pillow46, each of which constitutes an air impermeable compartment of its own.The pillow has a width of about 12 inches in one embodiment of thepresent positioning system.

As shown best in FIG. 3, the pillow 46 is connected to the bag 12 alonga hinge line 47 extending between reinforcement grommets 48 a, 48 b(FIGS. 1, 2), which preferably is formed by joining the top and bottomwalls 14, 16 by heat sealing, radio frequency welding or otherwise. Thepillow is free to pivot about the hinge line 47 toward the top wall orbottom wall. The pillow 46 provides support for the patient's head andneck, and may be inflated more or less based on the desired position andorientation for the patient's neck/head during the particular procedure,patient's anatomy and other factors. The pillow may be flipped forwardto rest on the top wall 14 to accommodate shorter patients.

The pillow preferably is made of the same material as the bag 12 itself.The pillow may be inflated by a number of conventional techniques, oneof which is a hand held inflation bulb 50 (FIG. 3) having a releasevalve 52 attached to a length of plastic tubing 54 in air-type fluidcommunication with the interior of the pillow. It will be appreciatedthat the pillow 46 provides independently adjustable support for thepatient's head and neck, allowing the surgeon or nurse to adjust thefirmness of the support as well as the position and orientation of thepatient's head and neck.

Referring to FIG. 8, the present positioning system may be provided witha disposable, waterproof slipcover 54 having a size and shape compatiblewith covering the top wall 14 of the bag 12, a top layer for fullycovering the top wall 14 and bottom layer for partially covering thebottom wall 16. The slipcover 54 is provided with slits 54 a, 54 b thatprovide side pocket openings in the bottom layer of the slipcover,similar to a throw pillow cover. The openings or pockets allow the sidesof the bag to be slipped into the slipcover side pockets such that thetop layer of the slipcover covers the top surface of the bag.

With reference to FIG. 9, the slipcover is formed from a rectangularpiece of fabric or material that is cut along cut lines 54 a, 54 b, 54c, 54 d, defining side panels 54 e, 54 f and central panel 54 g. Panels54 e, 54 f are then folded underneath central panel 54 g along foldlines 54 h, 54 i, and the edges 54 a, edges 54 b, edges 54 c, and edges54 d are each preferably heat sealed together to create the design shownin FIG. 8. In this way, the panels 54 e, 54 f form a pair of laterallyopposed, two-layer side pockets with respective portions of centralpanel 54 g.

FIG. 4 is a top plan view showing the positioning system supporting thepatient in a horizontal position on the operating table 40 duringsurgery. Air has been evacuated from the bag 12. The positioning system40 covers the patient's shoulders and provides lateral stabilizingsupport for the patient's head and neck. Lateral support also isprovided for the patient's upper arms, hips and upper thighs, whilestill providing easy access to the patient's forearms, wrist, and lowerlateral abdomen. The pillow 46 supports and orients the back of thepatient's head and neck.

FIG. 5 is a transverse sectional view of the positioning system, also inthe evacuated condition, taken across the patient's shoulders and upperchest. The positioning system envelopes the patient's upper arms and aportion of the patient's upper chest while providing malleable,comfortable underlying support for the patient's posterior. Thepositioning system readily conforms to the patient's anatomy.

FIG. 6 is a side elevation view showing an evacuated bag 12, operatingtable 40 and supine patient in a Reverse Trendelenburg position, withthe patient's head elevated above the feet. The patient's lower legstypically are secured to the table by one or more straps. The bag, whichconforms closely to the patient's anatomy, cooperates with the straps tocomfortably immobilize the patient and resist the force of gravityurging the patient to slide downwardly feet first. A foot boardoptionally may be placed adjacent the patient's feet. The positioningsystem partially envelops the patient and creates a friction contactwith the patient that must be overcome before the patient may sliderelative to the bag and operating table (which are effectively lockedtogether by the straps 38 a, 38 b, 38 c). The conformity of the bag tothe contours of the patient's body helps keep the patient from sliding.The wrist supporting portions 30 a, 30 b, when folded up, support thepatient's hands and wrists and also help create a narrow channel in thearea of the patient's hips, which is typically smaller than the width ofthe patient's shoulders, thereby resisting any tendency of the patientto slide down the inclined plane formed by the operating table.

FIG. 7 is a side elevation view showing an evacuated bag 12, operatingtable 40 and supine patient in a Steep Trendelenburg position, with thepatient's feet elevated above her head, and also in a Lateral Obliqueposition, with the patient tilted laterally to one side. FIG. 7 alsodepicts the patient with her legs slightly bent and feet spaced apartfor certain types of gynecological, laparoscopic, abdominal andurological procedures. It will be apparent that with the patient sopositioned the tendency of gravity is to cause the patient to slidedownwardly head first on the table and toward one side of the table.

The positioning system envelops the patient's shoulders and a portion ofher chest, creating a narrow channel around the patient's neck andshoulders to resist the tendency of the patient to slide eitherlaterally or longitudinally on the inclined plane formed by theoperating table. The system provides substantial bulk and mass in thearea of the patient's shoulders to help hold the patient in place. Thesystem's conformity to the patient's anatomy (lower back, spine,shoulder blades, etc.) contributes to hold the patient in place.

In using the surgical positioning system, the bag 12 is centered on theoperating table 40, with the pillow 46 toward the head of the operatingtable, and securely fastened to the table using the fastening straps 38a, 38 b, 38 c. The straps may be secured to the side rails of theoperating table. The bag is then smoothed out so that the internal beads42 inside are evenly distributed. The disposable waterproof slipcover 54is then placed over the bag 12 and tucked underneath.

The patient is then placed in the supine position on the bag with theneck and head resting on the pillow 46. In the case of smaller orshorter patients, the pillow can be folded forward before the patient isplaced in position. The inflation bulb 50 is then used to inflate thepillow as much as necessary to support and position the patient'shead/neck, typically in a neutral position for most surgeries.

The lateral sides of the bag are then folded upwardly to engage thesides, shoulders and upper arms, forearms and wrists of the patient. Thelateral and superior sides are snugly packed against the patient toaccommodate the natural contours thereof and provide a generallyU-shaped cradle for the patient. The top of the bag conforms to thepatient's posterior. While holding the patient and bag in the desiredposition, air is evacuated from the interior of the bag 12.Specifically, the female portion of the evacuation valve 44 is attachedto the male portion and a vacuum source is connected to the end of thefemale portion to evacuate air from the interior of the bag. Evacuationis continued until the bag is firm to provide contoured support for thepatient. When the desired level of support is achieved, the femaleportion is detached from the male portion and the vacuum source isdetached from the female portion. The bag retains its conforming shape.It will be appreciated that many types of known valve/hose constructionscan be used to create and release the vacuum.

Once the patient is secured, the operating table 40 may be inclined toplace the patient in the Steep Trendelenburg, Reverse Trendelenburg,Oblique Lateral or other inclined position for surgery. The positioningsystem uses different techniques to immobilize the patient in acomfortable manner while avoiding the application of significant localpressure to any specific region. The system spreads thecradling/supporting force over a relatively wide surface area of thepatient's anatomy and yet provides easy access to a large surface areaof the patient's anatomy, including the patient's forearms and lowerlateral abdomen. Significantly, the system retains the patient in placeby engaging a wide surface area of the patient in a way that eliminatespressure points. The bag's low profile in the vicinity of the patient'sforearms also allows surgical instruments to swing lower along the sideof the patient and allows the tips of medical instruments in the abdomento reach the inner aspect of the anterior abdominal wall with lessinterference from the side restraints of conventional systems. Yet, thepositioning system maintains contact with a sizable surface area of thepatient's anatomy, including the patient's shoulders, upper arms,forearms, hands, hips and thighs. Such surface contact provides afriction surface and contour fit to resist the tendency of the patientto slip or slide longitudinally relative to the bag.

The bag's overall design also provides protuberances or abutments thatserve as longitudinal obstructions for portions of the patient'sanatomy. These obstructions resist the gravity influenced tendency ofthe patient to slide or slip on the inclined operating table. Forexample, as shown in FIG. 7, the shoulder edge portions of the bagprovide a longitudinal and lateral barrier for the shoulders of apatient subject to a gravitational force urging the patient to slidehead first or laterally off the operating table. The wrist supportingportions restrain the patient's hands and arms from moving laterallyrelative to the operating table. As shown in FIG. 6, the wristsupporting portions/projections, when folded up, provide a longitudinaland lateral obstruction for the arms of a patient subject to agravitational force urging the patient to slide feet first or laterallyoff the operating table. In this case, the bag 12 also cooperates withleg straps 56, which typically are used to secure the patient's lowerlegs to the operating table.

The bag also is designed to create narrow channels to resist slidingmovement of the patient relative to the bag and the operating table.More specifically, as shown best in FIGS. 4 and 7, the bag defines arelatively narrow channel at the end where the patient's head is placed.The patient's shoulders, chest, and hips have a width dimension thatexceeds the width of the head/neck channel associated with the pillow46. Thus, when the patient is inclined head first, the narrow channeldefined at the head end of the bag prevents the wider portions of thepatient's anatomy from sliding longitudinally through the channel. Thechannel effect and shoulder wrap secures the patient even in thesteepest Trendelenburg position. In addition, the wrist supportingportions 30 a, 30 b also define a narrowing channel in the vicinity ofthe patient's hands and upper thighs. For a patient to slide feet firston the operating table relative to the bag, the patient's hips andshoulders, which are wider than the wrist channel, would have to slidethrough the narrow channel.

FIGS. 10 and 11 illustrate another embodiment of a surgical positioningsystem that has multiple chambers. For convenience, elements that arestructurally and/or functionally similar to those described above inother embodiments are designed with like reference numbers. Thus, forexample, surgical positioning system 112 comprises top and bottomopposing walls 114, 116 that are generally as described above withrespect to other embodiments. Top and bottom walls 114, 116 are joinedtogether at their upper, lower and lateral edges 118, 120, 122 forstrength and airtightness. As will be understood by the followingdescription, many of the features of the multi-chambered positioningdevices described below are common and/or similar to those of thesingle-chambered positioning devices described above. Moreover, as willbe understood by one of ordinary skill in the art, many features ofthese devices can be used interchangeably between the multi-chamberedand single-chambered devices.

Surgical positioning system 112 includes multiple chambers filled withbeads 42 to further facilitate positioning and securing the patientusing the positioning system. As shown in FIG. 11, which is a bottomview of surgical positioning system 112, a plurality of chambers areprovided in different areas of surgical positioning system 112.

Such chambers can be formed in a variety of manners. For example, in theembodiment shown in FIGS. 10 and 11, the plurality of chambers areformed by sealing portions of bottom walls 116 to top wall 114 (e.g., byheat sealing, radio frequency welding, etc.). By forming the variouschambers in this manner, the chambers may only visible from the bottomof the surgical positioning system 112. In other embodiments, however,the various chambers can be formed so that they are visible from boththe top and bottom sides of the positioning system 112. For example,FIG. 13 illustrates an embodiment where the different chambers 115, 117,119 are formed by sealing top wall 114 and bottom wall 116 so that thechambers are visible from the top side of the positioning system 112.

As shown in FIG. 11, a first main chamber 115 is provided in a centraland lower area of the surgical positioning system 112. In addition tomain chamber 115, secondary chambers 117, 119 are preferably positionedat locations that allow for the creation of greater fixation forcesbetween adjacent chambers to further restrict the movement of thepatient relative to the positioning system 112.

By forming a plurality of adjacent chambers of beads 42, surgicalpositioning system 112 can be formed with greater rigidity. As describedabove, in single chamber systems, the beads form a sold mass when air isremoved from the chamber. As the solid mass forms, the beads conform tothe patient to immobilize the patient in a desired position. Incontrast, by forming multiple solid masses by separately evacuatingadjacent chambers, not only do each of the solid masses conform to thepatient to immobilize the patient in the desired position, but adjacentsolid masses also interlock with one another to increase the rigidity ofthe system.

For example, by evacuating main chamber 115 first, main chamber 115forms a solid mass that at least partially conforms to the patient. Whenthe solid mass is formed, edges and surfaces of main chamber 115 formirregular surfaces (e.g., bends, folds, crinkles). As air is evacuatedfrom secondary chambers 117, 119, each of those chambers also forms asolid mass that at least partially conforms to the patient. In addition,as each of those solid masses is formed, edges and surfaces of secondarychambers 117, 119 also form irregular surfaces (e.g., bends, folds,crinkles).

As seen in FIG. 11, main chamber 115 has various edges and surfaces thatare adjacent to the edges and surfaces of at least a portion of one ofsecondary chambers 117, 119. After main chamber 115 and secondarychambers 117, 119 are evacuated, those adjacent edges and surfaces ofmain chamber 115 and secondary chambers 117, 119 are in contact with oneanother. Because of the irregularities of the surfaces of each of theevacuated chambers, the surfaces of secondary chambers 117, 119 at leastpartially interlock and/or form a frictional fit with the surface ofmain chamber 115. Such contact between the adjacent surfaces furtherincreases the rigidity of the positioning system 112 by increasingfriction between the adjacent surfaces, thereby restricting relativemovement of adjacent chambers. In this manner, the surgical positioningsystem can be used to further immobilize the patient in anticipation ofa surgical procedure.

Secondary chambers can be positioned on positioning system 112 wheregreater rigidity and strength can be particularly useful, such as at aportion on positioning system 112 where the most pressure is exerted bythe patient. For example, when a patient is in the Trendelenburgposition, this can be at an upper portion (e.g., shoulder region) of thepositioning system 112, where a large portion of the patient's weight isdirected.

As shown in FIG. 11, secondary chambers 117, 119 can be providedadjacent the upper portions of main chamber 115. FIGS. 12A and 12Billustrate end views of main chamber 115 and secondary chambers 117,119. FIGS. 12A and 12B are partial cross-sectional views that showchambers shown in cross-section for clarity. FIG. 12A illustrates thechambers in an unevacuated state, while FIG. 12B illustrates thechambers in an evacuated state. As shown in FIG. 12B, when the adjacentchambers are evacuated, the irregularities of the surfaces of each ofsecondary chambers 117, 119 at least partially interlock and/or form africtional fit with the surface of main chamber 115. As seen in FIG.12B, this contact increases the rigidity of the positioning system 112and restricting relative movement of adjacent chambers longitudinally(i.e., along the length of the patient) as well as laterally (i.e.,towards the sides of the patient). Thus, the surgical positioning systemcan further immobilize the patient by providing longitudinal and lateralsupport by the layered configuration shown in FIGS. 12A and 12B.

Thus, if the patient is in a Trendelenburg position, with his or herfeet above the head, the downward force exerted by the patient can be atleast partially countered by the frictional forces between adjacentedges and surfaces of the main chamber 115 and secondary chambers 117,119. As each of the chambers 115, 117, 119 conform to the patient,surfaces of the chambers contact and engage with surfaces of at leastone adjacent chamber to restrict relative movement between adjacentchambers.

Although the embodiment of FIGS. 12A and 12B illustrates secondarychambers 117, 119 on top of main chamber 115, it should be understoodthat secondary chambers 117, 119 could be positioned below main chamber115. In both embodiments, however, a surface of the secondary chambers117, 119 can engage a surface of main chamber 115 to restrict relativemovement between the contacting (i.e., frictionally engaged) surfaces ofthe chambers.

Multi-chambered positioning systems can be particularly useful for usewith bariatric patients. Bariatric patients are those patients thatexceed the physical size, shape, width, and/or weight of an averagepatient. It is not uncommon for bariatric patients to weigh in excess of300 pounds and, in some cases, over 400 pounds. Due to the increasedforces exerted by a bariatric patient on the support system, theadditional rigidity and support provided by the friction forces betweenadjacent chambers can be particularly helpful to immobilize and positionthe patient in the manners described above.

In bariatric applications, the positioning system's preferred width atits widest point can be significantly larger than in other applications.Thus for example, instead of about 42 inches, the width of thepositioning system can be about 54 inches which exceeds the shoulderwidth of most bariatric patients. The positioning system's preferredlength can also be longer, with its longest point about 51 inches. Thus,when the bariatric patient is placed in the supine position on thepositioning system 112, the lateral edges 122 can be folded up along thepatient's neck, shoulders, arms, hips and upper thighs and packedsnuggly against the bariatric patient's body to accommodate the naturalcontours thereof.

Referring again to FIG. 10, the upper edge 118 includes two opposedshoulder edge portions 124 a, 124 b, and a pillow edge portion 126located therebetween. As shown in FIG. 11, opposing shoulder edgeportions 124 a and 124 b are formed by respective secondary chambers117, 119. As in other embodiments, adjacent to the pillow edge portion126, the shoulder edge portions 124 a, 124 b can extend upward and awayfrom pillow edge portion 126 a distance greater than in otherembodiments. For example, in some embodiments, the shoulder edgeportions 124 a, 124 b can extend at least 4 inches, and preferably 5inches or more, from the pillow edge portion 126.

As in other embodiments, lateral edges 122 a, 122 b each define opposedcut-out portions 128 a, 128 b, and opposed projecting wrist supportingportions 130 a, 130 b. In the example, shown in FIG. 11, secondarychambers do not extend into cut-out portions 128 a, 128 b; however, itshould be understood that different shapes and configuration ofsecondary chambers are possible.

As shown in FIG. 11, a plurality of strap patches 134 a, 134 b, 134 c,and 134 d can be secured by any known manner, including, for example,heat sealing, radio frequency welding or otherwise to the bottom wall116. As in other embodiments, the patches preferably are centered andspaced apart along the positioning system's longitudinalcenterline/axis. Fastener straps such as those shown in FIGS. 7 and 8can be used to secure the positioning system 112 to an operating table40 (e.g., FIG. 4) on which the positioning system and patient aresupported. Straps can be secured to a respective Velcro® brandhook-and-loop fastener portion 135 a, 135 b, 135 c, and 135 d of thestrap patches. Alternatively, strap patches can comprise loop portionsthrough which straps can be positioned to secure the positioning systemto the table.

It will be appreciated that once the straps are secured to the operatingtable, the fixed attachment of the straps to the strap patches 134 a,134 b, 134 c (and effectively to the positioning system 112 as well),keep the positioning system from sliding laterally or longitudinally onthe operating table as, for example, when the table is tilted laterallywhile the patient in the Trendelenburg and other positions.

Additional strap and/or fastening systems can be used to further securethe patient and/or the positioning system to the table. For example, asshown in FIGS. 10 and 11, strap-receiving members 121 can be positionedat the lateral edges 122 a, 122 b of the positioning system 112.Strap-receiving members 121 can comprise loops or other such devicesthat are capable of receiving and securing a strap at the lateral edges122 a, 122 b. Strap-receiving members 121 can be secured to the lateraledges 122 a, 122 b in any known manner, such as the heat sealing, radiofrequency welding, stitching, etc. Once the positioning system 112 isevacuated so that it conforms to the patient, straps can be passedthrough the strap-receiving members (e.g., loops), around the patient,and to at least a portion of the operating table to further secure thepatient and positioning system 112 to the operating table. Such strapscan be particularly helpful when the operating table is tilted laterallyas such straps can further restrict lateral movement of positioningsystem 112 relative to the operating table.

The strap-receiving members 121 shown in FIGS. 10 and 11 are shownpositioned at lateral edges of a main chamber; however, it should beunderstood that such strap-receiving members 121 can be positioned atother locations on the positioning system 112, including for example, atother points along the lateral edge of the main chamber and at pointsalong other surfaces on the main chamber (e.g., on the top and/or bottomwalls). Such strap-receiving members can also be positioned on thesecondary chambers 117, 119 and/or adjacent those chambers if desired.

Positioning system 112 preferably is configured to wrap around andoverlie at least a portion of the patient's shoulders and upper chest,as described in other embodiments and as shown, for example, in FIG. 4.The straps that extend from strap-receiving members 121 and around thepatient can also reduce the width of the positioning system 112 in itsevacuated configuration. Thus, for example, if the positioning system112 has portions that “wing” or extend laterally over the edges of theoperating table, the straps can pull those portions of the positioningsystem 112 inward (i.e., towards the patient), thereby eliminating orreducing the amount that the positioning system 112 extends off theoperating table. This can be particular useful when using a largerpositioning system with bariatric patients because such positioningsystems (and the patients themselves) can be wider than the operatingtable.

The straps can be secured around or coupled to any available portion ofthe operating table. For example, the straps can be secured to a siderail or, in other embodiments, can extend around the bottom of the tableand be secured to another portion of the table or to itself.

In the exemplary embodiments that include multiple chambers describedabove, each of the various chambers can be evacuated independently ofthe evacuation of other chambers. Thus, as described above, main chamber115 can be evacuated before secondary chambers 117, 119 are sequentiallyor concurrently evacuated. To permit independent evacuation, each of thechambers 115, 117, 119 can have a valve 144 that communicates with theinteriors of the chambers 115, 117, 119 for evacuating air therefrom.Various possible valves are described in more detail above.

A valve lock can also be provided to lock the valve after evacuation toprevent an unintentional and/or accidentally release of the negativepressure applied to the positioning system during operation. FIGS. 14and 15 illustrate an exemplary valve system 201 that can be movedbetween an open and a closed position to allow or restrict,respectively, the flow of air into and out of the chambers associatedwith that valve system 201.

FIG. 14 illustrates a valve locking system that comprises a valve stem203, a main portion 211, and a moveable member 213 coupled to the mainportion 211. Moveable member 213 can be moved inward to open the valvesystem 201 and allow the ingress and egress of air from the chamberassociated with that valve system 201. An intermediate member 209 can bepositioned between main portion 211 and moveable member 213, with theintermediate member 209 forming a slot into which a lock member 207 canbe received. Lock member 207 can be formed in a C-shape so that it canbe received within the slot of the intermediate member 209.

As shown in FIG. 15, when lock member 207 is inserted into the slotformed between main portion 211 and moveable member 213, moveable member213 cannot be moved inward to the open position. Thus, lock member 207can secure the valve system 201 in a closed position and the chance ofvalve system 201 being accidentally opened during a surgical procedure(or at any other undesired time) can be significantly reduced.

At least one port can be provided in one or more of the top and bottomwalls 114, 116 to allow for the addition of beads to the positioningsystem 112. Because of the negative pressures applied to the beads, overtime, the beads can deteriorate and lose some functionality.Accordingly, the port allows access to the internal chamber(s) of thesystem so that additional beads can be added to system. Of course, theport can also allow for the removal or exchange of beads within thepositioning system. The port can comprise an opening that has a cover(e.g., a round cap) or removable member capable of allowing access tothe opening. Such ports can also be schematically depicted by a squarehinged member positioned along any surface of one or more chambers.Port(s) are preferably positioned on the bottom wall 116 of thepositioning system so that the port(s) are not located on the side ofthe positioning system that contacts the patient.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. I thereforeclaim as my invention all that comes within the scope and spirit ofthese claims.

The invention claimed is:
 1. A surgical positioning device for use witha patient, the surgical positioning device comprising a flexible airimpermeable shell having an interior region, the shell having an outerperiphery defined by an upper edge, a lower edge and opposite lateraledges extending between the upper edge and the lower edge, the shellbeing shaped to underlie a patient's head and torso during surgery andto wrap around the patient's shoulders during surgery, and a pluralityof beads substantially filling the interior region of the shell andpermitting the shell to be pliable prior to evacuation of air from theinterior region so that the shell is able to be wrapped around portionsof the patient, the shell rigidifying in response to air being evacuatedfrom the interior region, wherein the shell has shoulder portions thatwrap around the patient's shoulders and the shell has a head supportportion that underlies a patient's head, wherein the upper edge of theshell is shaped so that when the shell is lying flat, the shoulderportions extend beyond the head portion in a longitudinal dimension ofthe surgical positioning device.
 2. The surgical positioning device ofclaim 1, wherein each lateral edge of the opposite lateral edgesincludes a recessed portion defined between upper and lower portions ofthe respective lateral edge.
 3. The surgical positioning device of claim2, wherein the recessed portion comprises a concave arcuate shape. 4.The surgical positioning device of claim 2, wherein the shell isconfigured so that the recessed portions of the opposite lateral edgesare located adjacent the patient's waist.
 5. The surgical positioningdevice of claim 1, wherein the bottom edge includes a perineal cutout.6. The surgical positioning device of claim 1, further comprising atleast one fastener strap coupled to the shell and configured to coupleto a portion of a surgical table.
 7. The surgical positioning device ofclaim 6, wherein the fastener strap includes hook-and-loop fasteners. 8.The surgical positioning device of claim 6, further comprising at leastone strap fastening patch secured to the shell, the at least onefastener strap coupling to the strap fastening patch to couple the atleast one strap to the shell.
 9. The surgical positioning device ofclaim 1, further comprising at least one valve assembly in communicationwith the interior region of the shell.
 10. The surgical positioningdevice of claim 8, wherein the interior region is divided into aplurality of chambers, there being at least one valve assembly perchamber, each valve assembly having an open position to permit ingressof air into the respective chamber from the atmosphere and to permitevacuation of air from the respective chamber by a suction source. 11.The surgical positioning device of claim 9, wherein each valve assemblyincludes a locking member to restrict movement of the respective valveassembly to the open position.
 12. The surgical positioning device ofclaim 11, wherein the locking member is C-shaped.
 13. The surgicalpositioning device of claim 1, wherein the interior region of the shellis divided into a plurality of chambers.
 14. The surgical positioningdevice of claim 13, wherein the plurality of chambers includes a firstchamber, a second chamber, and a third chamber.
 15. The surgicalpositioning device of claim 14, wherein the shell includes a singlesheet of air-impermeable material that forms a bottom wall of each ofthe first, second, and third chambers.
 16. The surgical positioningdevice of claim 14, wherein the shell includes a single sheet ofair-impermeable material that forms a top wall of each of the first,second, and third chambers.
 17. The surgical positioning device of claim14, wherein the second and third chambers are included as part of theshoulder portions of the shell and wherein the first chamber includes aportion situated between the second and third chambers.
 18. The surgicalpositioning device of claim 1, wherein the head support portion isinflatable using a hand held bulb.
 19. The surgical positioning deviceof claim 18, wherein the interior region is divided into chambers, onechamber of which is associated with the head support portion.
 20. Thesurgical positioning device of claim 19, wherein the chamber of the headsupport portion is separated from at least one other chamber by a hingeline.